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Edited Transcript of DYAI.OQ earnings conference call or presentation 12-Nov-20 10:00pm GMT

·36 min read

Q3 2020 Dyadic International Inc Earnings Call Jupiter Nov 13, 2020 (Thomson StreetEvents) -- Edited Transcript of Dyadic International Inc earnings conference call or presentation Thursday, November 12, 2020 at 10:00:00pm GMT TEXT version of Transcript ================================================================================ Corporate Participants ================================================================================ * Mark A. Emalfarb Dyadic International, Inc. - Founder, CEO, President & Director * Matthew S. Jones Dyadic International, Inc. - MD of Business Development & Licensing * Ping Wang Rawson Dyadic International, Inc. - CFO ================================================================================ Conference Call Participants ================================================================================ * Ahu Demir NOBLE Capital Markets, Inc., Research Division - Biotechnology Research Analyst * John D. Vandermosten Zacks Investment Research, Inc. - Senior Biotechnology Research Analyst * Lee Alper * Robert Smith ================================================================================ Presentation -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- Good evening, ladies and gentlemen, and thank you for holding. Welcome to Dyadic International's Third Quarter 2020 Financial Results. (Operator Instructions) My name is Chuck, and I'll be your operator for today. As a reminder, please note that this call is being recorded. At this point, I would like to turn the call over to Ms. Ping Rawson, Dyadic's Chief Financial Officer. Please go ahead. -------------------------------------------------------------------------------- Ping Wang Rawson, Dyadic International, Inc. - CFO [2] -------------------------------------------------------------------------------- Thank you, Chuck. Good evening, everyone, and welcome to our third quarter 2020 earnings call. A press release with Dyadic International's third quarter 2020 financial results and the recent company highlights was issued earlier today. The press release on Form 8-K and Dyadic quarterly report on Form 10-Q have been posted to the SEC and Dyadic's website. On today's call, our President and CEO, Mark Emalfarb, will give a review of our business and corporate accomplishments for our third quarter of 2020, including a brief summary of our research and business development efforts. I will follow with a review of our financial results in more detail. We'll then provide you with an opportunity to ask questions. Matthew Jones and Ronen Tchelet will join Mark and I to answer your questions. At this time, I'd like to inform you that certain commentary made in this conference call may be considered forward-looking statements, which involve risks and uncertainties and other factors that could cause Dyadic's actual results, performance, scientific or otherwise, or achievements to be materially different from those expressed or implied by these forward-looking statements. Dyadic expressly disclaims any intent or obligation to update any forward-looking statements, except as required by law. For more information about factors that may cause actual results to be materially different from forward-looking statements, please refer to the press release we issued today as well as risks described in our annual report on Form 10-K for the year ended December 31, 2019, and our quarterly report on Form 10-Q for the quarter ended September 30, 2020, particularly in the section titled Risk Factors. This information can be found in other filings with the SEC when available. With that, I'd like to turn the call over to Mark. Mark? -------------------------------------------------------------------------------- Mark A. Emalfarb, Dyadic International, Inc. - Founder, CEO, President & Director [3] -------------------------------------------------------------------------------- Thank you, Ping. Welcome, everyone, and thank you for joining our third quarter conference call. I hope that you and your family are safe and healthy and are staying out of harm's way. This has been and continues to be a very exciting year for Dyadic. And Q3 has produced results and has gotten us closer to meeting our collective scientific and business objectives. We continued to advance our proprietary C1 gene expression platform into a safe and efficient expression system with improved properties, impressive scientific results. Our business development pipeline continues to grow with additional interest from both new and previously engaged collaborators, which we believe will accelerate the adoption and use of our C1 gene expression platform toward the goal of commercialization. In addition to our COVID-19 initiatives, we signed 6 new and expanded collaborations with human and animal health companies. Additionally, we are expanding our presence in the Asia Pacific region with the signing of a research collaboration agreement with Jiangsu Hengrui Medicine, the largest pharmaceutical company in China by market capitalization and our previously announced nonexclusive research collaboration with WuXi Biologics, a leading global CDMO. The agreement with Jiangsu Hengrui Medicine highlights C1's potential value proposition to address demand for more efficient biomanufacturing processes of biologic drugs and vaccines. In October, Dyadic entered into a nonexclusive technology agreement with Epygen Biotech of India, who after obtaining required funding, expects to produce cGMP clinical trial material at their facility and conduct trials in India using Dyadic's C1 expressed RBD antigen of the SARS-CoV-2 spike protein. This agreement demonstrates how potential collaborators globally can develop and manufacture vaccines and drugs on a regional basis that are affordable, safe and effective. With respect to our COVID-19 programs, we are currently working with 9 groups, including the Israel Institute for Biological Research, IIBR; the European ZAPI scientists; scientists from Oxford University, among others. And we anticipate that up to 10 animal trials will be completed by or shortly after year-end. This is in addition to the Frederick National Laboratory project that we announced in June, which is ongoing and showing encouraging expression data. Importantly, there will be trials with mice, hamsters and H2 transgenic mice, including challenge studies. We anticipate additional animal data to be generated to evaluate the best path forward for the potential clinical trial in humans. Interim results from a recent additional mice study further supports the C1 expressed SARS-CoV-2 RBD. In addition to generating excellent immunogenicity responses with very high titers and neutralizing antibodies against the COVID-19 virus, it also has the potential to stimulate a memory cellular immune response inducing human cells with a SARS-CoV-2 virus. We are in discussions with certain parties and have provided samples to those who have expressed additional interest in evaluating C1 to express SARS-CoV-2 vaccine in antibodies and for potential use for C1 expressed protein for diagnostic applications. As we previously mentioned, we have signed fully funded agreements with all 4 leading animal health companies as well as a fifth global animal health company to evaluate C1. The results from certain of our animal health programs have been very promising and therefore, we anticipate in 2021, one or more of the analog products we are working on will go into animal studies. And if successful, it will move towards commercialization. ZAPI has reported that they will continue to work on antigens for both the Schmallenberg, SBV, and Rift Valley Fever, RVFV viruses. ZAPI reported that they will conduct additional challenge studies in animals, which is expected to start before the end of the year with expected readouts in 2021. On the human health side, we signed 4 new and expanded collaborations with global pharmaceutical companies during the quarter. In some of these cases, we have moved beyond the proof-of-concept stage, and our collaborators have identified specific proteins for which they believe our C1 technology could be very beneficial to their commercialization efforts. In addition to entering into 2 fully human health collaborations today with top-tier global pharmaceutical companies, we are in various stages of discussions with other global pharmaceutical companies that we anticipate will lead to additional fully funded research collaborations and/or potential funded research agreements with negotiated license terms. The company continues to make progress in terms of stability and productivity in its glycoengineering and nonglycoengineering of its C1 cell lines to broaden the potential applications of the C1 gene expression platform for its use in developing and manufacturing vaccines, monoclonal antibodies and other therapeutic proteins. We continue to successfully advance our strategy through fully funded collaborations with leading pharma and biotech companies complemented by our solid cash and investment-grade securities of $30.5 million. Overall, we remain disciplined and opportunistic regarding capital allocation. The at-the-money, ATM, offering we put in place adds to our financial flexibility should we want to accelerate existing programs and pursue additional opportunities that leverage the broad and growing potential applications of C1. However, to date, we have not sold, and we are not obligated to sell, any shares under the ATM agreement and we have no immediate plans to sell any securities under this agreement to fund our near-term business plan. In closing, I believe that each quarter, we are making solid progress towards further establishing Dyadic's C1 gene expression platform as an alternative to CHO, baculovirus and other traditional expression technologies currently used in the development and manufacturing of biologic vaccines and drugs for use in animal and human health and to help combat infectious diseases. With that, I will turn the call over to Ping to review the financials. -------------------------------------------------------------------------------- Ping Wang Rawson, Dyadic International, Inc. - CFO [4] -------------------------------------------------------------------------------- Thank you, Mark. Before I begin my discussion, I'd like to provide you with a few key business and financial highlights. Dyadic's financial position is solid with approximately USD 30.5 million in cash and investment-grade securities and no debt. Our cash balance, USD 21.9 million, at the end of Q3 remains higher than in prior quarters due to the low interest rates currently available for investments. Our cash burn for the quarter and first 9 months of 2020 was approximately $1.5 million and $5.6 million, respectively, in line with previous quarters and our expectations. Importantly, our fully funded research collaborations continue to provide an additional source of revenue and partially offsets our ongoing R&D expenses. This has allowed us to mitigate our cash burn to a certain extent and maintain a comfortable position to fund our ongoing business activities. Overall, our approach to business development is unchanged to be optimistic with an emphasis on large and growing addressable markets in human and animal health. I will now discuss our financial results in greater detail. Turning to the income statement. R&D revenue for the quarter was approximately $416,000 compared to $455,000 for the quarter ended September 30, 2019. We reported a decrease in the cost of research and development revenue for the quarter of approximately $267,000, comparing to $385,000 for the quarter ended September 30, 2019. The decrease in revenue and cost of R&D revenue for the quarter reflected a lower level of funding per project from 8 ongoing research collaborations comparing to 5 collaborations for the same period a year ago. The increase in provision for contract losses of $112,000 reflected the activities of one biopharmaceutical collaboration research project. R&D expenses for the 3 months ended September 30, 2020, increased to approximately 800 -- $986,000 compared to $841,000 for the same period a year ago. The increase primarily reflects the expansion of our portfolio, which now includes COVID-19 projects as well as additional internal targeted research activities. There were no research and development expenses related party for the quarter ended September 30, 2020, compared to approximately USD 102,000 for the same period a year ago. The decrease was due to the completion of our Research Service Agreement with BDI in June 2019. G&A expenses for the quarter increased to approximately $1.6 million comparing to $1.1 million for the same period a year ago. The increase principally reflected increases in noncash share-based compensation expenses of $236,000, legal and SEC registration expenses of $217,000, accrued incentives of $54,000, insurance premium of $46,000 and miscellaneous increases of $34,000. Our interest income for the quarter was approximately $77,000 comparing to $245,000 for the same period a year ago. The decrease was primarily due to the lower interest rate environment on the company's investment-grade securities. The net loss for the third quarter of 2020 was approximately $2.5 million or $0.09 per share compared to $1.7 million or $0.06 per share reported for the same period a year ago. With that, I will turn the call back to the operator to open up for Q&A. ================================================================================ Questions and Answers -------------------------------------------------------------------------------- Operator [1] -------------------------------------------------------------------------------- (Operator Instructions) And our first question will come from Ahu Demir with NOBLE Capital. -------------------------------------------------------------------------------- Ahu Demir, NOBLE Capital Markets, Inc., Research Division - Biotechnology Research Analyst [2] -------------------------------------------------------------------------------- I was curious if you made any additional research on the RBD antibody for the coronavirus program. And if so, are there any improvements, although you got really good results previously. So I was just curious if there are any updates on that. -------------------------------------------------------------------------------- Mark A. Emalfarb, Dyadic International, Inc. - Founder, CEO, President & Director [3] -------------------------------------------------------------------------------- Yes, there are. So as we mentioned in the call, we not only have seen excellent immunogenicity and neutralization, but we're also seeing T cell response as well in the second mice trial, which supports what the IIBR mice trial did. In addition to that, we have increased the productivity in the last quarter from somewhere around approximately 1 gram per liter to 3-plus grams per liter in 4 days. So we made tremendous progress on that, and we've generated additional strains of C1 RBD that can be used for a variety of different vaccine candidates. And in addition, as we pointed out, we've successfully expressed one or more of the candidates for the Frederick National Laboratory, which, as you know, is part of the Vaccine Research Center and the NIH, Natural Infectious Disease Group, which of course, is related to Dr. Fauci. So I think we made significant advances. We've got data rolling in very shortly on some of the other animal data. As we mentioned, we expect up to 10 animal studies to be conducted on the RBD, C1 RBD, either with nanoparticles, on its own, with [ALM] and in mice, and Ace-2 transgenic mice challenge studies and in hamster studies and of course, in challenge studies with hamsters. So I see there's a lot going on. And of course, we're very excited about the results in terms of efficacy and obviously, the productivity for a long time, even in 1 gram per liter, a record level and now it's even higher so that we can make billions of doses even quicker and even lower cost. So hopefully, that answers your question about that. And in addition, as we reported, we also have now produced an antibody, monoclonal antibody from C1 for SARS-CoV-2, and it's looking very promising in terms of the initial data of neutralization. And that's in conjunction with a biotech firm called IDBiologics, and they licensed that monoclonal antibody gene from the Vanderbilt University in James Crowe's lab, who was one of the most renowned respected scientists in the field. So a lot going on and a lot of other people reaching out to us even today about potentially expressing additional antibodies in C1 for SARS-CoV-2. -------------------------------------------------------------------------------- Ahu Demir, NOBLE Capital Markets, Inc., Research Division - Biotechnology Research Analyst [4] -------------------------------------------------------------------------------- That sounds great. So my second question will be on the external programs. So considering you made many advances in the -- in your pipeline and also expanded your partnership portfolio, did it change in terms of how you conduct milestone or royalty payments currently? Did it change, by any means, with your partners? Have you talked to them in increase those milestones and how you approach them? So I was just curious. -------------------------------------------------------------------------------- Mark A. Emalfarb, Dyadic International, Inc. - Founder, CEO, President & Director [5] -------------------------------------------------------------------------------- Yes. There's really no changes. I mean those are all flexible upfront cash for excess fees, milestones, royalties, fully funded R&D programs, proof-of-concept, potential licensing. As I mentioned, we -- in addition to the deals we already made, including the 2 today that were signed, we're in discussions with others, leading to potentially funded research and even a potential one or more licenses for products and platform technology opportunities with several big pharma companies. -------------------------------------------------------------------------------- Ahu Demir, NOBLE Capital Markets, Inc., Research Division - Biotechnology Research Analyst [6] -------------------------------------------------------------------------------- And my last question will be on the glycoengineering. I know you mentioned that you made some progress. I am curious when we might see some data or some presentations on that side. -------------------------------------------------------------------------------- Mark A. Emalfarb, Dyadic International, Inc. - Founder, CEO, President & Director [7] -------------------------------------------------------------------------------- Yes. We continue to make significant progress on the glycoengineering and in the, I would say, merging of the low protease strain with the glycoengineering and then reconstituting the productivity. So a lot of the programs we're working on, in particular, one we're in negotiations with, is targeting, putting all that together, so we can make stable, high-quality, low-cost, glycoengineered monoclonal antibodies and other therapeutic proteins. So I'd say that we're on target for what we're doing there, and we are looking to make more deals targeted based on that success. -------------------------------------------------------------------------------- Operator [8] -------------------------------------------------------------------------------- (Operator Instructions) Our next question will come from John Vandermosten with Zacks CRC. -------------------------------------------------------------------------------- John D. Vandermosten, Zacks Investment Research, Inc. - Senior Biotechnology Research Analyst [9] -------------------------------------------------------------------------------- And congratulations on the 2 new agreements. I wanted to ask about those agreements and how specifically they're defined in terms of what proteins can be made under the agreement and if there's any restrictions on, I guess, what indications that they can pursue. How does that work when you're doing those contracts for them or those agreements with them? -------------------------------------------------------------------------------- Mark A. Emalfarb, Dyadic International, Inc. - Founder, CEO, President & Director [10] -------------------------------------------------------------------------------- Yes. First of all, I just want to highlight, we made 6 new agreements and several new agreements for COVID, just 6 in the animal health and human health. Those 2 were just the last 2 that we signed today. So to clarify that, we've got a lot of momentum going, and we're actually in discussions with additional ones that could have possibly come in even before this call. So hopefully, between now and the end of the year, we'll see some more deals. And specific to answer your questions, I think I'll let Matt, who I think is on the call, answer that. Matt, do you want to chime in? -------------------------------------------------------------------------------- Matthew S. Jones, Dyadic International, Inc. - MD of Business Development & Licensing [11] -------------------------------------------------------------------------------- Yes, sure. Thank you, Mark. A welcome to everybody on the call and I hope you're all safe and well. So John, part of the answer is that, of course, we are very conscious that the programs that we are involved with are mostly around enabling. Of course, COVID, a big topic for everybody right now. We are not different or immune to that. But there are many other conversations going on, and Mark's mentioned several new agreements, which may or may not be related to the pandemic type work. Actually, we are very conscious that C1 as a platform has many attributes for human and animal health. So we are pushing on all fronts. I think that the nature of the contracts remain confidential always. But what we can say is that the challenge of health care today is more and more real. And as we look at the effects of this pandemic and potentially future pandemics, the cost of health care is something which we can't get -- can't avoid anymore. So we are enabling companies who have had projects perhaps falter or stand still or go on the shelf with more classical cell lines who have turned now to C1. That -- those conversations were encouraging. We're also encouraging the diversity of what C1 can excrete, can produce in terms of types of molecules. And we've given public presentations. Indeed, our website has an updated presentation you can look at, everybody on this call, that talks to a very type of molecules, not just the vaccines or mAbs, other things also. And I think that's great. So I think we are conscious that nonexclusive licenses have been granted. We have not gone down any rabbit holes. We are certainly in a strong position. And just today, we were able to close 2 very important conversations, which we are very proud about. And we look forward to reporting when we can, John. And we're very -- we always adhere to confidentiality, and we won't change here. But range of molecules, range of opportunities, both in human and in animal health, yes, the pandemic is a big focus for a lot of conversations at the moment, but that does not take up more than a certain percentage of our focus. We still have a lot of other things that we're involved with. -------------------------------------------------------------------------------- Mark A. Emalfarb, Dyadic International, Inc. - Founder, CEO, President & Director [12] -------------------------------------------------------------------------------- And I think I can add a little bit, John, is I really think that this pandemic has highlighted the inefficiencies in the existing cell lines. And I think it's speeding up, let's say, the thought pattern, potential adoption and use of the pharmaceutical industry, the governments to come in and realize and recognize there's a big gap that needs to be filled. And we're helping make sure they understand how wide and deep their gap is and how C1 can fill that gap on so many different fronts. We can deal with not only animal and human health, but in the pandemic, we've developed C1 where we've been rapidly programming, very quickly, high levels of stable cell lines for production, quick purification. All that's come about through the sort of work in the last several years of knocking out proteases, glycoengineering, learning how to do better fermentations. I mean it's all coming together. So that investment in the R&D dollars and the investment in the dollars coming in from big pharma -- and as I think I mentioned in the last call, it isn't just the money. It's the analytics they're doing. It's the molecules they're giving us. They're giving us sort of a road map on how to get rid of which proteases are problematic over general classes. And we're learning from that. And as we now have a 14x protease knockout, we basically have a whole cell that's pretty much devoided the proteases. And if it's one on one, some protease pops up, we know how to knock it out and eliminate it in a much shorter, quicker fashion to get the ultimate result that we need of high stability, high productivity, high quality and low cost. So I think, to be honest with you, it's coming together. And as we've mentioned to you guys, it's all about the science, and the science is coming together. And now we're putting it together. As I mentioned earlier, we're taking the glycoengineering strains, the G0, the G2, and we're mixing those with the protease 14x knockouts and putting those both together in 1 strain and then trying to maintain or improve the productivity so that we can give the high quality with high stability and low cost and great flexibility. And I think everybody is starting to recognize that there's a new cell line that needs to be brought in. And we think we're ahead of that race, and we think that ours is a thoroughbred. And I think that, quite frankly, we're ahead of the game because we've been pushing on this. -------------------------------------------------------------------------------- John D. Vandermosten, Zacks Investment Research, Inc. - Senior Biotechnology Research Analyst [13] -------------------------------------------------------------------------------- And also kind of along the same lines on Jiangsu Hengrui, what might they be focused on? Are they going to be more focused on approved products or ones in development with the relationship you have with them? Will they be focused on biosimilars? I'm just wondering what are they going to do with the C1 line and how are they going to leverage it? Do you have a sense for that or? -------------------------------------------------------------------------------- Mark A. Emalfarb, Dyadic International, Inc. - Founder, CEO, President & Director [14] -------------------------------------------------------------------------------- Yes. I can give you a general sense because it's confidential, okay? But in general, I think it's more, let's say, new molecules rather than existing molecules, but it might be a molecule that's in a class that someone else may have that drug out there, which could be a multibillion drug. And they want to find a lower way to produce biologics, plain and simple. They want to dominate and reduce the cost of manufacturing because the Chinese government is putting huge pressure on these companies to lower their cost. And as Matt pointed out, and I think that the social unrest in our country and across the world, access to health care is becoming what it should be, an inalienable right. And there's no way you're going to deliver on that health care if you don't have a better host. And I give you a great example. I mean you see these companies out there making monoclonal antibodies, whether it be Eli Lilly, AstraZeneca or Regeneron for the monoclonal antibody for SARS-CoV-2, they're all saying they can't make enough. They don't have enough. They can't make enough. So we think C1 is a really good answer to supplement, not replace what CHO is doing because in that case, you got to make as much as you can possibly make and get these things out or people going to die because it's not going to have access to the antibodies when they need them. So if this pandemic continues to hang around, we have a solution. And I think that the quicker people recognize that, that solution if you put to practice, the better it will be for human kind. And I think people are starting to recognize that from governmental agencies and from big pharma. And we're hoping to hook a few of those and reel them in, okay? -------------------------------------------------------------------------------- John D. Vandermosten, Zacks Investment Research, Inc. - Senior Biotechnology Research Analyst [15] -------------------------------------------------------------------------------- Yes. And then Epygen Biotech of India, I guess that would be kind of similar as well to just take drugs that are already approved or biologics that are already approved and kind of have it a cheaper way for the domestic market in India? Is that the thought on that move? -------------------------------------------------------------------------------- Mark A. Emalfarb, Dyadic International, Inc. - Founder, CEO, President & Director [16] -------------------------------------------------------------------------------- Well, the initial thought with Epygen is to produce potentially 500 million doses of a low-cost vaccine that the Indian population can actually afford. So if they want to eradicate their pandemic, you got to get it to everybody or a mass part of the population. And to be honest with you, I think we have the best solution. And I know that people think, "Well, Pfizer came out. Sputnik's out. They're all coming out." We know all these guys are going to beat us at a punch. But what they're not going to do is, they're not going to beat us at a cost and the quantities that can be made. And we think ultimately, C1 are going to fill the void easy whether prime and a boost or sort of, let's say, lower income countries or the boost to some of these vaccines. And if this thing sticks around, as some people predict on a seasonal basis, water [sees] the lowest level. And we're going to be much lower cost to produce the vaccine. And we believe that the type of vaccine we have had tremendous benefits compared to what people are doing with the full spike protein. I don't know if people grasped or understood the difference of what we're doing versus what other people are doing. But if you look at warp speed, for example, all those vaccines from warp speed, as far as I remember, are the full spike. And we're not the full spike. We think we have a better approach and a safer approach because when you use the receptor binding domain, it's the key domain to go after the virus. We expose key neutralizing epitopes in the RBD to the immune system that are hidden in the closed spike confirmation. We have efficient induction of neutralizing antibodies by focusing the immune response to primary neutralizing epitopes. The RBD, as you can see, is easier to produce. It's 18x smaller than the spike trimer, so you get higher yields compared to the full-size spike protein. The immune response to the RBD, we believe when the data is coming in, that we believe it's going to be sufficient to protect from the disease. And then a recombinant protein vaccine as a boost of vaccine could be very good for vector immunity, to be a boost to a lot of these shots as well as a stand-alone vaccine and a potential universal boost strategy. And then again, we believe based on the past of these scientists from TiHo University, from Utrecht to Erasmus, who've been involved in SARS and CoV-2 -- or not CoV-2, coronavirus, it mirrors that it's a safer approach. You don't get enhanced respiratory disease, the ERD or the ADE, antibody-dependent enhancement. That probability is lower with the RBD alone than it is with the full spike. So this approach we took was not an approach we came up with on our own. We came up with these scientists who've been doing this for decades, who have the experience. And this is where they felt that this virus would be the safest to attack and would get the protection you need. And we just bring in the extra horsepower to produce massive amounts of it at very low cost and flexible commercial scale. So if this thing doesn't go away, I think we're going to be in great position and great shape. And no matter what, we're exposing this technology. It's being exposed to the world because of the pandemic, and they're seeing the advantages and avoid these other hosts have in productivity and cost. -------------------------------------------------------------------------------- John D. Vandermosten, Zacks Investment Research, Inc. - Senior Biotechnology Research Analyst [17] -------------------------------------------------------------------------------- Yes. Thanks for the extra tail on the RBD advantages. Last one for me is just on the Frederick Lab's next step, what's required before going into humans there? What are the milestones you've got to get before you're there? -------------------------------------------------------------------------------- Mark A. Emalfarb, Dyadic International, Inc. - Founder, CEO, President & Director [18] -------------------------------------------------------------------------------- Well, I'm not sure we need to make any more milestone because we think we've expressed one or more of the candidates successfully. We're going to -- as I mentioned, very soon, that we believe by the end of the month potentially, provide them with purified protein for them to evaluate and analyze. And from that point on, it's really up to them. And we're giving them what they need, providing it as the performance that they expect or they want. And based on what criteria they have, we're turning it over to them. So we're pretty much done. Can we improve it? Yes. Can we -- in terms of productivity. So it's productive enough, I believe, today, to make a vaccine at commercially feasible levels, but we can always make it more productive. And the question is, will they want to do that? And what they're going to do with it. But our part is almost done. -------------------------------------------------------------------------------- John D. Vandermosten, Zacks Investment Research, Inc. - Senior Biotechnology Research Analyst [19] -------------------------------------------------------------------------------- I guess they had to file an IND or something like that, I guess, right? And that's how we think moving forward. -------------------------------------------------------------------------------- Mark A. Emalfarb, Dyadic International, Inc. - Founder, CEO, President & Director [20] -------------------------------------------------------------------------------- Well, they probably have to do first animal studies and then an IND. -------------------------------------------------------------------------------- John D. Vandermosten, Zacks Investment Research, Inc. - Senior Biotechnology Research Analyst [21] -------------------------------------------------------------------------------- Okay. Yes, that's what I was wondering about what they would have. Okay. -------------------------------------------------------------------------------- Mark A. Emalfarb, Dyadic International, Inc. - Founder, CEO, President & Director [22] -------------------------------------------------------------------------------- But keep in mind, John, that we've opened the door, just like with ZAPI for them to come back over the next several years or decades to take advantage of the power, and flexibility and robustness because they've seen the ability of C1 to do things that they potentially couldn't have done in other ways. -------------------------------------------------------------------------------- Operator [23] -------------------------------------------------------------------------------- Our next question will come from Lee Alper with Hammock Investors. -------------------------------------------------------------------------------- Lee Alper, [24] -------------------------------------------------------------------------------- Got a couple. One, any update on Sanofi and what's holding that up? -------------------------------------------------------------------------------- Mark A. Emalfarb, Dyadic International, Inc. - Founder, CEO, President & Director [25] -------------------------------------------------------------------------------- Yes. I think the update on Sanofi is that they're still looking for where is the best place, if they can find a molecule, will they see the fit. They're busy, obviously, with COVID like anyone else. They have lots of opportunity. They have other expression cell lines that they can use, the things that are easy and cost of goods in the past and presently may not be their focus. But where they can't express something in sufficient quantities to advance it into the clinic or into preclinical studies, they're trying to find a home for us. Recently, I've actually spoken to them, and that's what they've told us. So they're looking for a place to use C1 to advance it in new potential animal studies in preclinical trials. But at the moment, they don't have a molecule they're ready to do that with. -------------------------------------------------------------------------------- Lee Alper, [26] -------------------------------------------------------------------------------- Okay. And along the same lines, has anyone walked away from you on the projects that they're working with? -------------------------------------------------------------------------------- Mark A. Emalfarb, Dyadic International, Inc. - Founder, CEO, President & Director [27] -------------------------------------------------------------------------------- I'll give you an example. I mean we did have a couple of years ago, one company that walked away, big pharma, and we're in discussions now they're back, okay? So Sanofi, of course, on the flu vaccine years ago walked away, and it wasn't because of the science, because of other reasons they might have had. So the answer is, of course, not every one of these people are going to move forward. But it's not necessarily -- and in most cases, it has nothing to do with the science and the programs and the research success. It's timing. It's finding the right molecule to put into a cell that provides them the benefit they're looking for. -------------------------------------------------------------------------------- Lee Alper, [28] -------------------------------------------------------------------------------- All right. And can you give us a little color on the patent exploration rights in 2029? What do you lose? And what do you keep? -------------------------------------------------------------------------------- Mark A. Emalfarb, Dyadic International, Inc. - Founder, CEO, President & Director [29] -------------------------------------------------------------------------------- Yes. Well, we don't lose anything. It's just in 2029, DuPont can actually then, other than for itself, potentially out-license C1, whatever it is they have in their possession. And so if they haven't evolved C1 and they're kind of like the Motorola 20-pound brick, and we have the iPhone 12, I'm not quite sure how competitive they're going to be. But we don't lose anything. And we've just gained a competitor. And to be honest with you, some ways if they were here now would make life easier because they could be in the clinic with their own candidate and product because the market is so huge, and the opportunities are so wide and diverse. I think in some ways, you could argue it would be beneficial if they actually had rights, and we're using them. And they have rights for themselves, but they're not in the drug business, and they can't sublicense it until 2029 December 31. So we still maintain our rights. -------------------------------------------------------------------------------- Lee Alper, [30] -------------------------------------------------------------------------------- Right. So in 2030, you'll still be able to do the medical side of it? -------------------------------------------------------------------------------- Mark A. Emalfarb, Dyadic International, Inc. - Founder, CEO, President & Director [31] -------------------------------------------------------------------------------- Yes. And by the way, our noncompete on the industrial side ends on January 1 this year. -------------------------------------------------------------------------------- Lee Alper, [32] -------------------------------------------------------------------------------- Okay. And one of your favorite lines is you have many shots on goal, but you seem to be stuck in a red zone. What's it going to take to get us over there on $1 deal? -------------------------------------------------------------------------------- Mark A. Emalfarb, Dyadic International, Inc. - Founder, CEO, President & Director [33] -------------------------------------------------------------------------------- Well, I don't think we're stuck in a red zone. I think we've moved from the 20-yard line to the 10-yard line. And then we're working on, for example, with the receptor binding domain, the data is coming in, as I mentioned, we have up to 10 animal studies. The efficacy and the performance is coming in. We already know the productivity is there. So we're working towards trying to get one or more of these vaccine candidates into humans. And I think once it gets into humans in a Phase I clinical trial, I think the gates start opening up almost like a flood gate, where we'll have more and more opportunity. So I think we're going to get there in 2021. And hopefully, we'll start in Q1 in 2021 to get there. -------------------------------------------------------------------------------- Operator [34] -------------------------------------------------------------------------------- Our next question will come from Robert Smith with Center for Performance Investing. -------------------------------------------------------------------------------- Robert Smith, [35] -------------------------------------------------------------------------------- So Mark, you just said it, aha. So you mentioned the first quarter. So is that a possibility of entering human clinical trials sometime in the first quarter? -------------------------------------------------------------------------------- Mark A. Emalfarb, Dyadic International, Inc. - Founder, CEO, President & Director [36] -------------------------------------------------------------------------------- Yes, it's a possibility of doing that. And it's actually a objective of ours that we're trying to meet. But we're trying to meet it, first and foremost, with one of our collaborator's checkbook rather than our own, if possible. We all want to save our money and use it for everything we can do. And if we can get someone else to help us fund that or completely fund it, that would be even better. -------------------------------------------------------------------------------- Robert Smith, [37] -------------------------------------------------------------------------------- Well, would you say that the understanding of knowledge of C1 is growing in the community? -------------------------------------------------------------------------------- Mark A. Emalfarb, Dyadic International, Inc. - Founder, CEO, President & Director [38] -------------------------------------------------------------------------------- Yes. I would say, if you remember, I think this guy Arthur, I don't know, Frentzel, or something like that, had this article way back 4 or 5 months ago, that the pandemic changes everything for C1. And I think absolutely, have we got more attention and we spend the potential adoption in use of C1 as the proof of principle that not only we've done with ZAPI, with SBV antigen, there was 300x more than to baculovirus to cattle results. They were safe, effective. The challenge studies were good. Now we've done the RVFV, the Rift Valley Fever virus, stably, baculovirus couldn't make it at all. Our own results with receptor binding domain, the high levels of productivity that are now reported at around 3 grams per liter in 4 days. And now the data is coming in. More and more animal data is just showing more and more safety and more and more efficacy, and the performance is there. So I think, yes, I think absolutely, the pandemic has changed everything for C1. And it's brought more eyeballs on what we're doing. And I hope we can be a solution to the world because it needs it. It's a more affordable way to mass produce biologics, whether it be for a pandemic or just traditional biologic drugs and vaccines. And I think people are starting to resonate with that opportunity. -------------------------------------------------------------------------------- Robert Smith, [39] -------------------------------------------------------------------------------- Yes. I see so much -- so many comments about production and distribution, but I don't actually see the mention of what you have there, I mean, as far as the multiples of what could be gained. So that's a puzzle to me. -------------------------------------------------------------------------------- Mark A. Emalfarb, Dyadic International, Inc. - Founder, CEO, President & Director [40] -------------------------------------------------------------------------------- Well, I'll tell you the multiple that we can gain. You've got -- I don't know. I think it was Pfizer who just came out, and they said they're going to make 1.3 billion doses in 2021. So that's an entire year. They're going to have enough for 2 shots, which is I think 650,000 patients worldwide, and we need 16 billion shots potentially, right? If you don't even need boosters and it continues on and on and on. So if we wanted to make 1.3 billion doses, I believe if we had the wherewithal financially, we can do it in a month, not in a year. So that gives you kind of the difference at a lower cost with potentially safe -- as safe of a vaccine that may or may not because we don't know the efficacy in humans be just as good. -------------------------------------------------------------------------------- Robert Smith, [41] -------------------------------------------------------------------------------- No, I fully understand that, but why doesn't Pfizer? -------------------------------------------------------------------------------- Mark A. Emalfarb, Dyadic International, Inc. - Founder, CEO, President & Director [42] -------------------------------------------------------------------------------- Well, Pfizer took an approach through -- I don't know, it was mRNA or DNA. I don't remember the exact approach. But they probably do it. But a lot of these pharma guys take what they have and they just use it. And then they get stuck. It's kind of like you start a clinical trial and you get to Phase I, and you're not going to go back. You just keep pushing ahead. Why they don't do it? I don't -- ask the CEO of Pfizer. I think somebody should be asking this question to all the CEOs. -------------------------------------------------------------------------------- Robert Smith, [43] -------------------------------------------------------------------------------- Okay. I agree with you. -------------------------------------------------------------------------------- Mark A. Emalfarb, Dyadic International, Inc. - Founder, CEO, President & Director [44] -------------------------------------------------------------------------------- But we're asking the question, I can assure you, okay? -------------------------------------------------------------------------------- Operator [45] -------------------------------------------------------------------------------- I am showing no further questions at this time, and we'll now turn the call back to Mr. Emalfarb for any closing remarks. Please go ahead. -------------------------------------------------------------------------------- Mark A. Emalfarb, Dyadic International, Inc. - Founder, CEO, President & Director [46] -------------------------------------------------------------------------------- Okay. Thank you, Chuck. 2020 continues to be a very exciting year for Dyadic. As we've just discussed, the pandemic has positively increased C1's visibility globally. The promising scientific data has enabled us to move closer to meeting our collective scientific and business objectives and strengthens our resolve to find a way to move a C1 expressed vaccine antibody or other therapeutic protein into clinical trials. I'd like to thank all of our employees, directors and vendors for their tireless focus and dedication during these challenging times. I'd also like to take -- and thank our shareholders for your patience as we continue to work together to bring health care to a global population. We've made very strong progress so far this year, and we look forward to ending the year even better positioned than we are today. Thank you for your time today, and stay safe. -------------------------------------------------------------------------------- Operator [47] -------------------------------------------------------------------------------- The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.